A Study to Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function

NCT01419041

Last updated date
Study Location
Pfizer Investigational Site
Anaheim, California, 92801, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Impairment
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

All Subjects

- Healthy male and/or female of non childbearing potential subjects between the ages of 18 and 65 years, inclusive ('healthy' is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG, and clinical laboratory tests).

- Body Mass Index (BMI) of 18 to 40 kg/m2 inclusive; and a total body weight >50 kg (>110 lbs).

Subjects with Normal Renal Function (Group 1)

- Normal renal function (CLcr =>90 mL/min) during the screening period.

- Matched 1-to-1 to subjects in Group 2 with respect to age (+/-5 years), weight (+/-10 kg), gender, and race according to protocol.

Subjects with Severe Renal Impairment (Groups 2)

- Good general health commensurate with the population with chronic kidney disease.

- Severe renal impairment (CLcr<30 mL/min) during the screening period.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


All Subjects


- Renal allograft recipients.


- Any condition possibly affecting drug absorption.


- 12 lead ECG demonstrating QTc >470 msec at screening.


- Urinary incontinence without catheterization.


- A positive urine drug screen.


- History of regular alcohol consumption.


- Treatment with an investigational drug within 30 days (or as determined by the local
requirement, whichever is longer) or 5 half lives preceding the first dose of study
medication.


- Pregnant or nursing females; females of childbearing potential, including those with
tubal ligation.


- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.


Subjects with Severe Renal Impairment (Groups 2)


- Subjects with any significant hepatic, cardiac or pulmonary disease (apart from stable
ischemic heart disease), or subjects who are clinically nephrotic.


- Subjects requiring hemodialysis.


- Subjects with strict fluid restriction (ie, <1500 mL/24 hours).


- Significant bleeding diathesis which could preclude multiple venipuncture.


- Use of food or drugs that are CYP3A4 inhibitors and inducers.


- Herbal supplements and hormone replacement therapy must be discontinued 28 days prior
to the first dose of trial medication


- Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function
Official Title  ICMJE A Phase I, Single Dose, Parallel-Group Study To Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function
Brief Summary The present study is being conducted to evaluate whether or not severe renal impairment has an effect on crizotinib Pharmacokinetics.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Renal Impairment
Intervention  ICMJE
  • Drug: crizotinib
    Single-dose oral 250 mg crizotinib in subjects with normal renal function (CLcr =>90 mL/min)
  • Drug: crizotinib
    Single-dose oral 250 mg crizotinib in subjects with severe renal impairment (CLcr <30 mL/min)
Study Arms  ICMJE
  • Arm A
    CLCR: Creatinine clearance
    Intervention: Drug: crizotinib
  • Arm B
    CLCR: Creatinine clearance
    Intervention: Drug: crizotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 11, 2011)
16
Original Estimated Enrollment  ICMJE
 (submitted: August 16, 2011)
24
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

All Subjects

  • Healthy male and/or female of non childbearing potential subjects between the ages of 18 and 65 years, inclusive ('healthy' is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG, and clinical laboratory tests).
  • Body Mass Index (BMI) of 18 to 40 kg/m2 inclusive; and a total body weight >50 kg (>110 lbs).

Subjects with Normal Renal Function (Group 1)

  • Normal renal function (CLcr =>90 mL/min) during the screening period.
  • Matched 1-to-1 to subjects in Group 2 with respect to age (+/-5 years), weight (+/-10 kg), gender, and race according to protocol.

Subjects with Severe Renal Impairment (Groups 2)

  • Good general health commensurate with the population with chronic kidney disease.
  • Severe renal impairment (CLcr<30 mL/min) during the screening period.

Exclusion Criteria:

All Subjects

  • Renal allograft recipients.
  • Any condition possibly affecting drug absorption.
  • 12 lead ECG demonstrating QTc >470 msec at screening.
  • Urinary incontinence without catheterization.
  • A positive urine drug screen.
  • History of regular alcohol consumption.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half lives preceding the first dose of study medication.
  • Pregnant or nursing females; females of childbearing potential, including those with tubal ligation.
  • Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.

Subjects with Severe Renal Impairment (Groups 2)

  • Subjects with any significant hepatic, cardiac or pulmonary disease (apart from stable ischemic heart disease), or subjects who are clinically nephrotic.
  • Subjects requiring hemodialysis.
  • Subjects with strict fluid restriction (ie, <1500 mL/24 hours).
  • Significant bleeding diathesis which could preclude multiple venipuncture.
  • Use of food or drugs that are CYP3A4 inhibitors and inducers.
  • Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of trial medication
  • Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01419041
Other Study ID Numbers  ICMJE A8081020
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP